Department of Radiology and Institute of Rehabilitation and Imaging of Brain Function, Nanchong Central Hospital, The Second Clinical Medical College of North Sichuan Medical College, 97 South Renmin Road, Shunqing District, Nanchong, 637000, Sichuan, China.
Department of Big Data Center, Sichuan Cancer Hospital and Institute, Chengdu, 610000, China.
Acta Neurol Belg. 2021 Aug;121(4):993-999. doi: 10.1007/s13760-020-01460-w. Epub 2020 Aug 8.
Previous studies have shown that placebo repetitive transcranial magnetic stimulation (rTMS) was effective on post-stroke motor rehabilitation. However, the placebo effect has not been systematically assessed. Therefore, this meta-analysis was conducted to resolve this issue and explore potential influencing factors further. PubMed, Embase, web of science and the Cochrane Library were searched for published randomised controlled trials (RCTs) with placebo rTMS treatment of stroke recovery until May 2019. The placebo effect size (Hedges' g) was estimated using the motor outcome of pre- and post- placebo rTMS treatment. Meta-regression analysis was also performed to explore potential influencing factors for the placebo effect. Twenty-six placebo-controlled trials (including 381 patients in placebo group) were selected. Effect size results (Hedges' g = 0.466, 95% CI 0.207-0.726; P < 0.05) showed a medium and significant placebo rTMS effect on improving post-stroke motor recovery. The mean ratio of the effect size of sham to real stimulation was 56%. Meta-regression analysis did not find significant result except for the treatment sessions, which was significantly correlated with the placebo effect size (r = 0.465, p = 0.031). In the follow-up observations (1, 2 and 3 months), the sham rTMS groups manifested gradually increased motor improvement, which was similar to the real group, but the amplitude was lower, which was sustained for at least 3 months. Placebo effect of rTMS on post-stroke motor recovery was medium but significant. Regarding different sham styles, the number of stimulation sessions had an impact on the effect.
先前的研究表明,安慰剂重复经颅磁刺激(rTMS)对脑卒中后运动康复有效。然而,安慰剂效应尚未得到系统评估。因此,进行了这项荟萃分析以解决这个问题,并进一步探索潜在的影响因素。检索了 PubMed、Embase、Web of Science 和 Cochrane Library 中截至 2019 年 5 月发表的安慰剂 rTMS 治疗脑卒中后康复的随机对照试验(RCT)。使用安慰剂 rTMS 治疗前后的运动结局估计安慰剂效应量(Hedges'g)。还进行了荟萃回归分析,以探讨影响安慰剂效应的潜在因素。选择了 26 项安慰剂对照试验(包括安慰剂组 381 例患者)。效应量结果(Hedges'g=0.466,95%CI 0.207-0.726;P<0.05)表明,安慰剂 rTMS 对改善脑卒中后运动康复有中等且显著的作用。假刺激与真刺激的效应量比值的平均值为 56%。荟萃回归分析除了治疗疗程外,未发现显著结果,而治疗疗程与安慰剂效应量显著相关(r=0.465,p=0.031)。在随访观察(1、2 和 3 个月)中,假 rTMS 组表现出逐渐增加的运动改善,与真刺激组相似,但幅度较低,至少持续 3 个月。rTMS 对脑卒中后运动康复的安慰剂效应为中等但显著。关于不同的假刺激方式,刺激次数对效应有影响。